{"id":17677,"date":"2018-07-06T06:44:54","date_gmt":"2018-07-06T06:44:54","guid":{"rendered":"https:\/\/arisglobal.com\/bkp-site\/?p=17677"},"modified":"2018-07-06T06:44:54","modified_gmt":"2018-07-06T06:44:54","slug":"leading-global-pharmaceutical-company-selects-lifesphere-susar-reporting","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/leading-global-pharmaceutical-company-selects-lifesphere-susar-reporting\/","title":{"rendered":"Leading Global Pharmaceutical Company selects LifeSphere Safety Document Distribution Reporting"},"content":{"rendered":"<h2>Business Problem<\/h2>\n<p>A leading global pharmaceutical company managed the distribution of safety reports by their clinical operations team. However, the company\u2019s multitude of global recipients had various preferences on how they wished to receive these reports, making it difficult to centrally manage the acknowledgment and be compliant. Additionally, gathering the recipient\u2019s details, including mailing address or fax number from a third party CTMS system to distribute the reports, proved to be time-consuming and error-prone to manage. The preparation of envelopes was manual and distribution was completed via courier or fax. Further, the tracking of distribution and acknowledgment was managed in a spreadsheet.<\/p>\n<h3>Solution evaluation<\/h3>\n<p>The customer evaluated multiple systems to overcome its current challenges. Key evaluation objectives included:<\/p>\n<ul>\n<li>Ease of use<\/li>\n<li>Interoperability: Ability to integrate with other systems<\/li>\n<li>Support for varied distribution methods<\/li>\n<\/ul>\n<p>ArisGlobal LifeSphere Safety Document Distribution Reporting was selected after extensive evaluation of the product with respect to key objectives and overall implementation approach.<br \/>\nThe solution is integrated with LifeSphere MultiVigilance (Safety case processing system) and LifeSphere CTMS (Investigator and site database). Further, the system is enabled for eFAX and web portal options to make it easy for investigators to receive safety notifications.<\/p>\n<h2>Implementation Approach &amp; Timelines<\/h2>\n<p>ArisGlobal deployed a fully validated application, hosted on the managed cloud to minimize the IT effort for the customer. The detailed implementation and study\/sponsor onboarding plan was prepared and executed by an experienced ArisGlobal team working jointly with customer\u2019s team.<br \/>\n<strong>Project Duration: <\/strong>Four months (including preparation and go-live activities)<\/p>\n<h3>Key Activities<\/h3>\n<ul>\n<li>1-day workshop with business and IT users to plan the implementation<\/li>\n<li>2-day configuration workshop<\/li>\n<li>Configure integration with LifeSphere Safety MultiVigilance, CTMS and eFAX system<\/li>\n<li>Configuration of the distribution rules at system, study, country and recipient level<\/li>\n<li>Build cover letter and notification templates<\/li>\n<li>Validate the overall system configuration and integration scenarios<\/li>\n<li>Training\n<ul>\n<li>A detailed training strategy was led by customer<\/li>\n<li>Courses for internal users<\/li>\n<li>Step-step guide for investigators<\/li>\n<\/ul>\n<\/li>\n<li>Production deployment<\/li>\n<li>Go-live<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ul>\n<h2>Value proposition<\/h2>\n<ul>\n<li>Streamlined process with significant reduction in cost<\/li>\n<li>Enhanced traceability:\n<ul>\n<li>ArisGlobal\u2019s LifeSphere Safety Document Distribution Reporting is a fully validated system that can track both distribution of safety reports and receipt by individual investigators\/sites<\/li>\n<\/ul>\n<\/li>\n<li>Automation of manual process steps<\/li>\n<li>Facilitating process consistency\u00a0and cost reduction\n<ul>\n<li>Enhanced security, with a system that is access-controlled via individual user accounts<\/li>\n<li>Accessibility through a system that is web-based and therefore safety reports can be accessed remotely<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h1>Conclusion<\/h1>\n<p>Successful implementation of ArisGlobal LifeSphere Safety Document Distribution Reporting for global studies with single process, resulting in improved safety reporting processes, greater efficiency with notifications, ability to achieve timely distribution and reduced costs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A leading global pharmaceutical company selected LifeSphere SUSAR Reporting to streamline safety reporting process. The pharma company worked in partnership with ArisGlobal to ensure greater efficiency with notifications, ability to achieve timely distribution and reduced costs. Read more\u2026<\/p>\n","protected":false},"author":27,"featured_media":39762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[],"class_list":["post-17677","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Leading Global Pharmaceutical Company selects LifeSphere Safety Document Distribution<\/title>\n<meta name=\"description\" content=\"A leading global pharmaceutical company selected LifeSphere Safety Document Distribution Reporting to streamline safety reporting process. The pharma company worked in partnership with ArisGlobal to ensure greater efficiency with notifications, ability to achieve timely distribution and reduced costs. Read more\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arisglobal.com\/clinical-case-study\/leading-global-pharmaceutical-company-selects-lifesphere-susar-reporting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Leading Global Pharmaceutical Company selects LifeSphere Safety Document Distribution Reporting\" \/>\n<meta property=\"og:description\" content=\"A leading global pharmaceutical company selected LifeSphere Safety Document Distribution Reporting to streamline safety reporting process. 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